Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-10 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-In claim 3, line 3, the phrase “maintains a normal serum IGF-1 level in the human,” and in claim 4, line 3, the phrase “maintains serum IGF-1 at ≤1.0x the upper limit of normal (ULN) in the human,” renders the claims indefinite. Neither the instant specification nor the prior art teach a definitive baseline “normal” serum IGF-1 level. As such, the metes and bounds of the claim are unascertainable.
-In claim 5, it is not clear what “maintains IGF-1 levels in the human for up to 51 weeks,” is referencing as a baseline. It is not clear if this maintenance IGF-1 level is an IGF-1 baseline level that is known in the art for patients with acromegaly, or if it is the IGF-1 level following administration of compound A after a set period of time, or if it is the IGF-1 level that was achieved during treatment with the somatostatin analog.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT03792555 (published 02/13/2020, PTO-892), as evidenced by PubChem (Paltusotine, PTO-892).
Regarding claim 1, ‘555 teaches a method of treating acromegaly by administering CRN00808 to patients that are responders to octreotide or lanreotide (“Official Title”). ‘555 specifically teaches its patients as those with confirmed acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot (“Eligibility”).
‘555 teaches CRN00808 as administered orally (Arms and Interventions).
As evidenced by the instant specification, Compound A is paltusotine, as evidenced by PubChem is paltusotine is CRN00808.
Regarding claim 2, while ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population in the same dosage amounts (amounts effective to treat acromegaly), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
See also MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
Regarding claim 10, ’55 teaches octreotide and lanreotide.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US2020/0190053 to Zhao (published 2020, IDS of 07/24/2024) in view of NCT03792555 (published 02/13/2020, PTO-892).
Zhao teaches a method of treating acromegaly in a human comprising orally administering, daily, instant compound A or salts thereof (pgs. 171-172, claims 21, 24-28).
Zhao differs from that of instant claim 1 in that it does not teach the human as previously treated with and responded to and tolerated treatment with a somatostatin analog.
NCT03792555 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the patient population of NCT ‘555, i.e., patients that are responders to octreotide or lanreotide, as the humans treated in the methods of Zhao, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Zhao and ‘555 are both directed toward methods of treating acromegaly by administering oral selective nonpeptide somatostatin receptor type 2 agonists (Study Description of ‘555; [0088], [0090]-[0093], [0095], [0101], [1344]), and
-Zhao teaches peptide drugs, such as octreotide and pasireotide, as extremely expensive and as requiring frequent doctor’s office visits for painful injections that can lead to injection site reactions ([0005]).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating acromegaly that is less expensive, less painful, and less time consuming/complicated, thereby increasing patient compliance and effectiveness of treatment.
Regarding claim 2, while the combination of Zhao and ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that the combined method of Zhao and ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population, in the same dosage amounts (the instant claims teaches 0.01-100 mg/day ([00164], and Zhao teaches administration of 0.01-2000mg/day ([1021])), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
See also MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
Regarding claims 6-7, Zhao teaches administration of 0.01-2000mg/day ([1021]) and teaches that amounts effective depend on the severity and course of the disease or condition, previous therapy, the patient’s health status, weight, and response to the drugs, and the judgement of the treating physician ([1016]-[1017]).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, MPEP 2144.05. The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 8-9, Zhao teaches hydrochloride acid as a pharmaceutically acceptable salt of compound A ([0921]).
Regarding claim 10, the combination of Zhao and ‘555 teach octreotide and lanreotide.
Claims 1-10 are rendered obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14, 25-30 of U.S. Patent No. 11,266,641 (IDS of 07/24/2024) in view of NCT03792555 (published 02/13/2020, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘641 claims a method of treating acromegaly by orally administering a tablet comprising a tablet comprising the monohydrochloride salt of compound A comprising about 10, 20, 30, 40, 50, 60, 70 or 80mg of the monohydrochloride salt of compound A (claims 13, 26).
‘641 claims the compound administered once daily (claim 27).
‘641 differs from that of instant claim 1 in that it does not teach the human as previously treated with and responded to and tolerated treatment with a somatostatin analog.
NCT03792555 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the patient population of NCT ‘555, i.e., patients that are responders to octreotide or lanreotide, as the humans treated in the methods of ‘641, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘641 and ‘555 are both directed toward methods of treating acromegaly by administering oral selective nonpeptide somatostatin receptor type 2 agonists, and
-‘555 teaches such as methods as effective in patients that are responders to octreotide or lanreotide.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating acromegaly in patients previously responding to octreotide or lanreotide.
Regarding claim 2, while the combination of ‘641 and ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that the combined method of ‘641 and ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population, in dosage amounts effective to treat acromegaly, as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
‘641 additionally claims instant compound A or salts thereof, and tablets comprising instant compound A or salts thereof (claims 1, 12-14)
‘641 additionally claims the hydrochloride salts of instant compound A (claims 11, 14).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”. See Col, 8, line 45-Col. 9, line 5, Col. 22, lines 25-Col. 23, line 13).
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,957,674 (IDS of 08/28/2024) in view of NCT03792555 (published 02/13/2020, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘674 claims a method of suppressing growth hormone, insulin, glucagon, IGF-1, prolactin or combination thereof in humans with acromegaly by orally administering instant compound A or a salt thereof (claims 1-2).
‘674 claims the monohydrochloride salt of instant compound A and claims administration of an amount equivalent to about 20mg to about 60mg of instant compound A monohydrochloride salt (claim 4).
‘674 claims administration once daily to the human (claim 5).
‘674 differs from that of instant claim 1 in that it does not teach the human as previously treated with and responded to and tolerated treatment with a somatostatin analog.
NCT03792555 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the patient population of NCT ‘555, i.e., patients that are responders to octreotide or lanreotide, as the humans treated in the methods of ‘674, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘674 and ‘555 are both directed toward methods of treating acromegaly by administering oral selective nonpeptide somatostatin receptor type 2 agonists, and
-‘555 teaches such as methods as effective in patients that are responders to octreotide or lanreotide.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating acromegaly in patients previously responding to octreotide or lanreotide.
Regarding claim 2, while the combination of ‘674 and ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that the combined method of ‘674 and ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population in dosage amounts effective to treat acromegaly, as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
Claims 1-7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14, 25-30 of U.S. Patent No. 12,617,767 (PTO-892) in view of NCT03792555 (published 02/13/2020, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘767 claims a method of treating acromegaly by administering a mesylate salt of instant compound A (claim 16).
‘767 claims a mesylate salt of instant compound A (claims 1, 15).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘767 teaches the compound for use in treating acromegaly administered orally in amounts of 0.01-2000mg/day (Col. 6, lines 48-55; Col. 9, lines 58-60; Col. 52, lines 21-27).
‘767 differs from that of instant claim 1 in that it does not teach the human as previously treated with and responded to and tolerated treatment with a somatostatin analog.
NCT03792555 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the patient population of NCT ‘555, i.e., patients that are responders to octreotide or lanreotide, as the humans treated in the methods of ‘767, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘767 and ‘555 are both directed toward methods of treating acromegaly by administering oral selective nonpeptide somatostatin receptor type 2 agonists, and
-‘555 teaches such as methods as effective in patients that are responders to octreotide or lanreotide.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating acromegaly in patients previously responding to octreotide or lanreotide.
Regarding claim 2, while the combination of ‘767 and ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that the combined method of ‘767 and ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population in dosage amounts effective to treat acromegaly, as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-32 of copending Application No. 18/599,998 (claim set dated 08/14/2024) in view of NCT03792555 (published 02/13/2020, PTO-892).
This is a provisional nonstatutory double patenting rejection.
‘998 claims a dispersion comprising instant compound A or a pharmaceutically acceptable salt thereof, such as the monohydrochloride salt (claims 31-32).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘998 teaches compound A as treating acromegaly by orally administering compound A in amounts of 10-100mg daily ([0021], [0023]-[0024], [0035]-[0036], [0040], [00120]-[00121], [00124]).
NCT03792555 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the patient population of NCT ‘555, i.e., patients that are responders to octreotide or lanreotide, as the humans treated in the methods of taught by ‘998, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘998 and ‘555 are both directed toward methods of treating acromegaly by administering oral selective nonpeptide somatostatin receptor type 2 agonists, and
-‘555 teaches such as methods as effective in patients that are responders to octreotide or lanreotide.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating acromegaly in patients previously responding to octreotide or lanreotide.
Regarding claim 2, while the combination of ‘998 and ‘555 does not explicitly teach the patient as maintaining IGF-1 levels at levels comparable to prior treatment with the somatostatin analog, it is reasonable to assume that the combined method of ‘998 and ‘555 would have the same properties since it treats the same disease by administering the same compound to the same patient population in dosage amounts effective to treat acromegaly, as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 3-5, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the instant case, the wherein clause expresses the desired result of the positive step of administering instant compound A to a patient with acromegaly who was previously treated with, and responded to and tolerated treatment with a somatostatin analog. Thus, this limitation is met.
Regarding claims 7-9, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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